Double row collapsible suture construct

ABSTRACT

Tissue fixation and repair constructs and methods of repair using the same are provided. An exemplary tissue fixation and repair construct can include a first implantable anchor coupled to a suture having a fixed tail and a tensioning tail. The fixed tail can include an overhand knot located distally adjacent to the finger trap, such that the overhand knot substantially abuts the finger trap when adjacent thereto, a fixed stopper knot configured to prevent further movement of the fixed tail through a second implantable anchor when the second implantable anchor is placed onto the suture, and a finger trap. The tensioning tail can be passed through the finger trap and overhand knot, and can be used to adjust the tension of the tissue fixation and repair construct when the first implantable anchor and the second implantable anchor are inserted into bone.

FIELD

The present disclosure relates generally to double row collapsiblesuture constructs.

BACKGROUND

A variety of injuries and conditions require repair of soft tissuedamage, or reattachment of soft tissue to bone and/or surroundingtissue. For example, when otherwise healthy tissue has been torn awayfrom a bone, such as a shoulder rotator cuff tendon being partially orcompletely torn from a humerus (a rotator cuff tear), surgery is oftenrequired to reattach the tissue to the bone, to allow healing and anatural reattachment to occur. A number of devices and methods have beendeveloped for performing these surgical repairs. Some of the moresuccessful methods including the use of suture fixation members, such assuture anchors, which typically include an anchor body having one ormore suture attachment feature and include a tissue or bone engagingfeature for retaining the suture anchor within or adjacent to the tissueor bone. Depending on the specific injury, one or more suture anchorsconnected to, or interconnected by, one or more segment of suture, maybe used to perform the repair.

Surgery can also be required when a tear occurs in the substance of asingle type of tissue. Sutures can also be used in conjunction with oneor more suture anchors to repair such tissue tears. Sutures can befastened to suture anchors and to tissue using knots tied by the surgeonduring a repair procedure, or using “knotless” devices and methods,where one or more anchors and one or more sutures can be connected andtensioned without the surgeon needing to tie knots during the surgery.Knotless anchoring is of particular utility for minimally invasivesurgeries, such as endoscopic or arthroscopic repairs, where the surgeonremotely manipulates the suture at the surgical site using toolsinserted through a small diameter cannula or endoscopic tube, which canmake the knotting process difficult and tedious.

However, current techniques for double-row fixation require the tensionof the suture to be set while the anchor is inserted, and as such it canbe difficult to reliably set the correct amount of tension. In addition,current techniques require the use of multiple anchors for both medialand lateral rows. Furthermore, with current techniques and fixationdevice designs, the suture retention capacity for a lateral row anchoris relatively low, as the suture is often compressed between the boneand the anchor.

Accordingly, there remains a need for improved tissue repair devices,systems, and methods.

SUMMARY

In an aspect, a tissue repair construct is provided and can include afirst implantable anchor and a flexible member. The first implantableanchor can include an engagement member and at least one bone engagingfeature on an outer sidewall of the first implantable anchor. Theflexible member can include an intermediate portion coupled to theengagement member, and first and second tails extending from theintermediate portion. Each of the first and second tails can include aterminal end. A portion of the first tail can extend through an interiorcollapsible passage formed in a portion of the second tail and a firstknot formed in the second tail adjacent to the hollow portion. Thesecond tail can include a fixed knot intermediate the first knot and theterminal end of the second tail.

In some embodiments, the intermediate portion can be slidably coupled tothe engagement member. In other embodiments, the tissue repair constructcan include a second implantable anchor configured to be coupled to thesecond tail. In such embodiments, the second implantable anchor can bedisposed proximate the fixed knot. In yet other embodiments, theterminal end of the first tail can be configured to be coupled to thesecond tail. In still other embodiments, the terminal end of the firsttail is configured to be separated from the second tail. In someembodiments, the distance between the fixed knot and the first knot canbe disposed at a distance from the fixed knot, the distanceapproximately equal to 3-5 mm more than a length of the firstimplantable anchor. In other embodiments, the interior collapsiblepassage can be configured to be disposed outside of a bone when thefirst implantable anchor is disposed in the bone.

In another aspect, a method is provided. The method can includeinserting a tissue repair construct into a first bone hole, the tissuerepair construct including a first implantable anchor having anengagement member and at least one bone engaging feature on an outersidewall thereof, and a flexible member coupled to the engagement memberand at least one tail extending therefrom, wherein the flexible memberis spliced to itself to form a loop proximal to the first implantableanchor; passing at least a portion of the flexible member through oraround soft tissue; coupling the flexible member to a second implantableanchor; inserting the second implantable anchor and at least a portionof the flexible member into a second bone hole; and tensioning theflexible member after the second implantable anchor is inserted into thesecond bone hole so as to apply and set a desired amount of tension inthe repair construct.

In some embodiments, the flexible member can have an intermediateportion coupled to the engagement member with first and second tailsextending therefrom, each of which has a terminal end and wherein theflexible member is spliced by passing the first tail through a portionof the second tail. In such an embodiment, the method can include,following the passing step, separating the terminal end of the firsttail from the second tail and coupling the flexible member to the secondanchor by inserting the terminal end of the second tail into the secondimplantable anchor. In other embodiments, a distal end of the flexiblemember can be coupled to the first implantable anchor, and the secondanchor can be coupled to the second implantable anchor by coupling theloop in the flexible member to a coupling suture attached to the secondimplantable anchor.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a schematic view of one embodiment of a tissue fixation andrepair construct;

FIG. 2a is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 1 during an initial step of a surgicalprocedure in which a first implantable anchor is inserted into a holeformed in bone;

FIG. 2b is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 1 during a subsequent step in a surgicalprocedure in which a portion of the construct is passed through a softtissue;

FIG. 2c is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 1 during a subsequent step in a surgicalprocedure in which a second hole is formed in bone;

FIG. 2d is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 1 during a subsequent step in a surgicalprocedure in which a tensioning tail of a flexible member is separatedfrom a fixed tail of the tensioning member;

FIG. 2e is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 1 during a subsequent step in a surgicalprocedure in which the fixed tail is coupled with a second anchor to beimplanted in the second hole;

FIG. 2f is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 1 during a subsequent step in a surgicalprocedure in which the second anchor is implanted into the second hole;

FIG. 2g is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 1 during a subsequent step in a surgicalprocedure in which the tensioning tail is tensioned to approximate thesoft tissue to bone;

FIG. 3 is a side cross-sectional schematic illustration of an exemplarytechnique for coupling the flexible member of the tissue fixation andrepair construct of FIG. 1 with the second anchor;

FIG. 4 is a side cross-sectional schematic view of an additionalembodiment of a tissue fixation and repair construct having multipleflexible members coupled to an implantable anchor;

FIG. 5 is a side cross-sectional schematic view of one embodiment of atissue fixation and repair construct;

FIG. 6a is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 5 during an initial step of a surgicalprocedure in which a first implantable anchor is inserted into a holeformed in bone;

FIG. 6b is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 5 during a subsequent step in a surgicalprocedure in which a portion of the construct is passed through a softtissue;

FIG. 6c is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 5 during a subsequent step in a surgicalprocedure in which a second hole is formed in bone;

FIG. 6d is a side cross-sectional schematic view of the tissue fixationand repair construct of FIG. 5 during a subsequent step in a surgicalprocedure in which the second anchor is implanted into the second hole;and

FIG. 7 is an overhead schematic view of an exemplary embodiment of adouble row rotator cuff repair according to techniques disclosed herein.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Further, in the present disclosure, like-named components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-named component is notnecessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. Sizes and shapes ofthe systems and devices, and the components thereof, can depend at leaston the anatomy of the subject in which the systems and devices will beused, the size and shape of components with which the systems anddevices will be used, and the methods and procedures in which thesystems and devices will be used.

The figures provided herein are not necessarily to scale. Further, tothe extent arrows are used to describe a direction a component can betensioned or pulled, these arrows are illustrative and in no way limitthe direction the respective component can be tensioned or pulled. Aperson skilled in the art will recognize other ways and directions forcreating the desired tension or movement. Likewise, while in someembodiments movement of one component is described with respect toanother, a person skilled in the art will recognize that other movementsare possible. Additionally, although terms such as “first” and “second”are used to describe various aspects of a component, e.g., a first endand a second end, such use is not indicative that one component comesbefore the other. Use of terms of this nature may be used to distinguishtwo similar components or features, and often such first and secondcomponents can be used interchangeably. Still further, a number of termsmay be used throughout the disclosure interchangeably but will beunderstood by a person skilled in the art.

Soft tissue fixation and repair constructs and methods of soft tissuerepair using the same, and kits including the same are provided. Theseconstructs are particularly useful in double-row fixation repair, e.g.,for rotator cuff repair, and include an implantable anchor that hascoupled thereto a collapsible loop. After the anchor is implanted intobone, such as on the medial side, and the flexible member is passedthrough or around soft tissue, the flexible element can be coupled to asecond implantable anchor, such as a knotless anchor for a lateral row,and the second anchor is implanted into bone. Among the advantages ofthe construct described herein is the fact that tension can be appliedto the flexible member to tighten the flexible loop through a knotlesstechnique and compress the soft tissue to bone after the anchors areinserted into bone. A drawback of many current techniques is thattension can only be applied while the second anchor is being inserted,thus making it difficult to control tension. The soft tissue fixationand repair constructs and methods of soft tissue repair described hereinprovide for stronger lateral row fixation through a more convenient andless time consuming procedure. A further advantage of the constructs andtechniques disclosed herein is the ability to use the same type ofanchor for both the medial and lateral rows, which is typically not thecase in current practice.

FIG. 1 illustrates one embodiment of a tissue fixation and repairconstruct 10 configured to be implanted in a body of a patient tofacilitate soft tissue repair. The tissue fixation and repair construct10 includes a first implantable anchor 12, such as a medial anchor thatis configured to be inserted into a hole that has been formed in bone,with a flexible member 14 coupled thereto. In an exemplary embodimentthe first implantable anchor 12 has at least one bone engaging feature16 located on an outer sidewall thereof. Further, in someimplementations, the first implantable anchor 12 is cannulated, having alumen 18 extending therethrough, with a first flexible member engagementfeature 20 spanning the lumen 18 at a distal end 12 d of the implantableanchor 12. The flexible member can include a first tail 22, a secondtail 24, and an intermediate portion 26 disposed between the first tail22 and the second tail 24. The first tail 22 can be a tensioning tailthat can be used by a surgeon to adjust the overall tension of theflexible member 14 during installation of the tissue fixation and repairconstruct 10. The second tail 24 can be a fixed tail upon which variousfeatures can be formed, such as an overhand knot 28, a fixed stopperknot 30, and a finger trap 32, each of which is discussed in furtherdetail below. The first tail 22 and the second tail 24 can optionally becoupled together by a terminating splice 34.

As shown in FIGS. 1-2 g, the tissue fixation and repair constructincludes a first implantable anchor 12 that is configured to beimplanted in bone in a secure manner. In such constructs, theimplantable anchor is configured to couple to a suture and to be used ina tissue repair procedure, e.g., for soft tissue reattachment or repairat a joint such as the hip, knee, or shoulder, and in particular arotator cuff repair procedure.

One skilled in the art will appreciate that a variety a suture anchortypes can be used in conjunction with the constructs provided herein,including both hard and soft anchors, and including screw-type anchors,and that the disclosure is not intended to be limited to the designs ofanchors provided for herein. Some exemplary embodiments of anchors thatcan be used in conjunction with the constructs and related teachingsprovided for herein include a Healix™ anchor, a Healix Advance™ anchor,a Healix Advance™ Knotless anchor, a Versalok™ anchor, and a Gryphon™anchor, each of which is commercially available from DePuy Mitek Inc.325 Paramount Drive, Raynham, Mass. 02767, as well as anchors describedin U.S. Pat. No. 9,345,567, entitled “Systems, Devices, and Methods forSecuring Tissue Using Snare Assemblies and Soft Anchors” and U.S. Pat.No. 9,763,655, entitled “Systems, Devices, and Methods for SecuringTissue Using Hard Anchors,” the content of each of which is incorporatedby reference herein in their entireties. One skilled in the art willfurther appreciate that the implantable anchors can be made from avariety of well-known materials, including those that are absorbable andnon-absorbable. Further, the implantable anchors can have any of avariety of sizes as appropriate for use at a particular anatomicallocation and with a particular patient.

The suture anchors described herein are configured to maintainengagement with a flexible member, such as a suture material. As shownin FIGS. 1-2 g, for example, the first implantable anchor 12 has aproximal end 12 p and a distal end 12 d disposed opposite the proximalend 12 p. The distal end 12 d of the first implantable anchor 12 isconfigured to be inserted into a hole formed in bone, such as first bonehole 36. The first implantable anchor is cannulated and, as such, has alumen 18 extending therethrough from the proximal end to the distal end.As shown, the lumen 18 is cylindrically shaped, however a variety oflumen shapes are possible. The first implantable anchor 12 can alsoinclude a flexible member engagement feature 20 that spans across thelumen 18 at the distal end 12 d and that is configured to retain aportion of the flexible member 14 in engagement with the suture anchorand disposed within the lumen 18. Alternatively, the anchor 12 need nothave a lumen 18, but can have the flexible engagement feature 20 at theproximal end 12 p, or it may include a proximal eyelet to engage withthe flexible member 14. An exemplary embodiment of such an anchor, whichcan be used in conjunction with the constructs and relating teachingsprovided for herein, include a Spiralok anchor, which is commerciallyavailable from DePuy Mitek, Inc.

The suture anchors also include at least one feature to facilitatesecure engagement in bone. By way of example, first implantable anchor12 includes bone engaging features 16 formed on an outer sidewallthereof and configured to engage with the first bone hole 36 and therebysecure the first implantable anchor 12 in place. As shown in FIG. 1, insome implementations, the bone engaging feature 16 can comprise aplurality of protrusions that extend from an outer sidewall 12 o of thefirst implantable anchor 12. The protrusions can be in the form of barbsand/or threads, or any similar structure that enables the anchor toobtain purchase with bone and remain securely attached to bone.

The flexible member 14 of the tissue fixation and repair construct 10can be a filament or suture material, such as a suture thread and/or asuture tape. One skilled in the art will appreciate that the filament orsuture material can be any type and material typically used as filament,including a cannulated filament, a braided filament, and a monofilament. The type and strength of the filament can depend, at least inpart, on the other components with which the construct is used, such asthe suture anchor, the tissue through which it will be passed or coupledto, and the type of procedure in which it is used. In some embodimentsthe filament can have a size between about a #5 filament (about 20 gaugeto about 21 gauge) and about a #5-0 filament (about 35 gauge to about 38gauge), and in one exemplary embodiment the filament is a #2 filament(about 22 gauge to about 24 gauge), such as an Ortbocord™ filament thatis commercially available from DePuy Mitek, Inc., or an Ethibond™filament that is commercially available from Ethicon, Inc., Route 22West, Somerville, N.J. 08876. The flexible member 14 can be any type ofsuture and can be made from a variety of well-known materials, includingnatural materials and synthetic materials. Examples of materials for theflexible member include polymers, such as polyglycolide, polypropylene,polyethylene terephthalate (PET), and polydioxanone, and fabrics, suchas nylon and silk. The flexible member 14 can be bioabsorbable,partially bioabsorbable, or nonabsorbable, and can have a circular crosssection or another cross section, such as square or rectangular. Theflexible member 14 can also be hollow.

The thickness of the filament should provide strength in the connectionbut at the same time minimize the trauma caused to tissue through whichit passes. In some embodiments, different portions of the tissuefixation and repair construct 10 can have different thicknesses, withthe thickness being based, at least in part, on the purpose for thatportion, the thicknesses of the other portions of the construct, thecomponents or tissue through which that portion may be passed, and thetype of procedure in which the construct is used. Orthocord™ suture isapproximately 55 to 65 percent PDS™ polydioxanone, which isbioabsorbable, and the remaining 35 to 45 percent ultra-high molecularweight polyethylene, while Ethibond™ suture is primarily high strengthpolyester. The amount and type of bioabsorbable material, if any,utilized in the filaments of the present disclosure is primarily amatter of surgeon preference for the particular surgical procedure to beperformed.

The flexible member 14 can be formed from a single thread or from aplurality of threads. The plurality of threads can be coupled togetherto define a flexible member strand in any of a variety of ways, such asby being braided together. In an exemplary embodiment, the thread(s)that form the flexible member 14 are sufficiently flexible to allow thesuture to be flexible. The threads that form the flexible member 14 canmade from different materials, e.g., a first number of the threads beingnylon and a second number of the threads being PET, or, all threads ofthe flexible member 14 can be made from the same material. A flexiblemember 14 formed from a plurality of threads can, in some embodiments,include a core around which the threads are arranged, such as bybraiding. The core may provide the suture with strength to help preventthe suture from breaking, snapping, etc. The suture can have any of avariety of sizes, such as a size in a range of about size #5 to #5-0.

When applied to form the construct 10, and as shown in FIGS. 1-2 g, theflexible member has a first tail 22, a second tail 24, and anintermediate portion 26 disposed between the first tail and the secondtail. The first tail 22 can be a tensioning tail that can be used toadjust the tension of the suture during installation of the construct ina surgical procedure. The second tail 24 is a fixed tail that caninclude such features as an overhand knot, a fixed stopper knot, and afinger trap which are described in further detail below.

With continued reference to FIGS. 1-2 g, the second tail 24 of theflexible member 14 has an overhand knot 28 formed thereon, which islocated distally adjacent to the finger trap 32 relative to the firstimplantable anchor 12, such that the overhand knot 28 substantiallyabuts the finger trap 32. The overhand knot 28 is configured to helpmaintain the integrity of the finger trap 32, and to enable the firsttail 22 to pass through the overhand knot 28 in such a way that thefirst tail 22 can be slidably moved through the overhand knot 28 inresponse to tension applied by a surgeon. A person skilled in the artwill appreciate that although a small gap may exist between the overhandknot 28 and the finger trap 32 such that the overhand knot 28 does notabut the finger trap 32 so as to be in direct contact with the fingertrap 32, the overhand knot 28 can nevertheless be considered tosubstantially abut the finger trap 32 due to any number of facts, suchas manufacturing tolerance. Although the overhand knot 28 is shown anddescribed as an overhand knot, which may be beneficial in surgicalprocedures due to its low profile, any type of knot known to one ofordinary skill in the art that is capable of achieving the functionalitydescribed herein may also be used in lieu of an overhand knot, such as ahitch knot. The overhand knot 28 is formed by the flexible member 14itself. However, in other embodiments, another flexible member can beattached to the flexible member 14 to form the overhand knot 28 (e.g.,tied around the flexible member 14 to form the overhand knot 28thereon).

The second tail 24 of the flexible member 14 also has a fixed stopperknot 30 formed thereon. As explained in further detail below, the fixedstopper knot 30 is configured to maintain engagement between theflexible member 14, and particularly second tail 24, and thus preventmovement of the second tail 24 through a second implantable anchor 38(shown in FIGS. 2e-2g ). The second implantable anchor 38, as describedin more detail below, can be the same type of suture anchor as the firstimplantable anchor 12, and thus have the same structures and features asthe first implantable anchor 12. By way of example, the secondimplantable anchor 38 can be used in a lateral row of a double-rowrepair construct. Affixation of the second implantable anchor 38 to theflexible member 14 is described in more detail below in connection witha discussion of the method of using construct 10. In any event, tomaintain engagement between the second tail 24 and the secondimplantable anchor 38, the diameter of the fixed stopper knot 30 shouldbe greater than the space between the flexible member engagement feature40 of second implantable anchor 38 and the wall of the lumen 42 of thesecond implantable anchor 38. This structure prevents the fixed stopperknot 30 from fully entering the second lumen 42 and thus the second tail24 remains connected to the second implantable anchor 38.

The fixed stopper knot 30 is positioned on the second tail 24 at aparticular location that is sufficiently spaced from the finger trap 32and the overhand knot 28 such that operation of the finger trap 32 isnot impeded and so that the finger trap remains spaced from the bonehole in which the second implantable anchor 38 is to be placed. A personskilled in the art will appreciate that this predetermined distance willvary depending on a variety of factors, including the size of theanchors used and the procedure and anatomy involved. Typically thepredetermined distance is about 5-15 mm, and typically about 10 mm,greater than the length of the second implantable anchor 38.

The finger trap 32 useful with the construct 10 disclosed herein cantake a variety of forms as long as it allows the tensioning tail 22 topass therethrough. In general, the finger trap 32 is an area of theflexible member 14 that is hollow and through which the flexible memberpasses through itself. For example, the first tail 22, when undertension, is slidable uni-directionally in a first direction D1 throughthe finger trap 32 and is locked from sliding through the finger trap 32in the other, opposite direction D2 because the tension collapses thefinger trap 32 on the portion of the first tail 22 of the suture passingtherethrough. Exemplary finger traps are described in detail in U.S.patent application Ser. No. 15/622,360 filed on Jun. 14, 2017 andentitled “Finger Traps for Collapsible Suture Loops,” the disclosure ofwhich is incorporated by reference herein in its entirety.

The flexible member 14 of the construct 10 defines an adjustable loop 44that includes partial portions of each of the first tail 22 and thesecond tail 24, and the entirety of the intermediate portion 26. Aspreviously mentioned, the flexible member 14 can be tensioned by asurgeon by pulling on the first tail 22 to slide a portion of theflexible member 14 through the finger trap 32. This tensioning collapsesthe adjustable loop 44 and reduces a distance between the finger trap 32and the first implantable anchor 12.

An exemplary method of fixing soft tissue, such as a tendon 46, usingthe tissue fixation and repair construct 10 is described with referenceto FIGS. 2a-2g . The method illustrated in FIGS. 2a-2g is performed in aminimally invasive manner, e.g., arthroscopically, through a cannula,such as cannula 48, that can be disposed through a patient's skin usingtechniques known to those skilled in the art. In the illustratedembodiment, the cannula is substantially aligned with the location atwhich the procedure is performed and serves as a working channel throughwhich the tissue fixation and repair construct 10 and various toolsrequired to perform the procedure are passed. A person skilled in theart will recognize other ways by which the procedures described hereincan be performed, including through three or more cannulas, a singlecannula, or through no cannula at all. Further, other types ofprocedures, such as open procedures, can be used in conjunction with thepresent disclosures, which may not require a cannula such as cannula 48.

FIG. 2a shows the tissue fixation and repair construct of FIG. 1,wherein the first implantable anchor 12 has been inserted into the firstbone hole 36 that has been formed in a portion of a bone 50. A varietyof commonly known tools and methods can be used to form the first bonehole 36, such as a drill. The first bone hole 36 can be disposed at alocation proximate to the location at which the tendon 46 is to beattached to the bone 50. After the first bone hole 36 has been formed,the tissue fixation and repair construct 10 can then be passed throughthe cannula and implanted in the first bone hole 36 using ordinarytechniques, such as by using a driver to screw or tap the anchor intoplace. As shown, the first tail 22 is coupled to the second tail 24 viathe terminating splice 34 during the insertion. And while the anchor andthe intermediate portion of the flexible member are disposed within thebone hole and the subject's body, the remainder of the construct 10extends out of the subject's body and out of the cannula 48.

FIG. 2b shows the tissue fixation and repair construct of FIG. 1,wherein a portion of the flexible member 14 has been passed through thetendon 46 after the first implantable anchor 12 has been inserted intothe first bone hole 36. As the end of the first tail 22 is coupled tothe second tail 24 via the terminating splice 34, the number of separatetails passed through or around the tendon 46 and the cannula 48 can bereduced, and thus the passage of the flexible member 14 through thetendon 46 is simplified. While the first tail 22 and the second tail 24can be passed through or around tissue such as tendon 46 using a numberof techniques known to those skilled in the art, in some embodiments asuture passing device such as the EXPRESSEW II flexible suture passer,which is available from DePuy Mitek, LLC, can be passed through thecannula 46 and operated to pass the first tail 22 and the second tail 24through the tendon 46.

Subsequently, a second bone hole 52 is then formed in a portion of bone50 adjacent to first bone hole 36, as shown in FIG. 2c . This can beaccomplished using tools and methods that are similar to or the same asthose used to create the first bone hole 36. As will be explained infurther detail below, the second bone hole 52 is configured to receivethe second implantable anchor 38 that can be coupled to the tissuefixation and repair construct 10. The second implantable anchor 38 canbe of the same type as or similar to the first implantable anchor, asshown in FIG. 2e . The end of the first tail 22 is separated from thesecond tail 24 after the portion of the flexible member 14 has beenpassed through the tendon 46, as shown in FIG. 2 d.

The flexible member 14 is then coupled to the second implantable anchor38 by inserting the second tail 24 into the second lumen 42 of thesecond implantable anchor 38, such that the second tail 24 extends intothe distal end 38 d of the second implantable anchor 38 toward aproximal end 38 p of the second implantable anchor 38. In doing so, thefixed stopper knot 30 engages the flexible member engaging member 40 ofthe second implantable anchor 38, allowing the terminal portion ofsecond tail 24 to pass through the proximal end 38 p of secondimplantable anchor 38 while preventing passage therethrough of the fixedstopper knot 30 as shown in FIG. 2e . As the fixed stopper knot 30 has alarger diameter than the at least one passageway of the secondimplantable anchor, the fixed stopper knot 30 cannot pass through the atleast one passageway of the second implantable anchor 38 and thusconstrains the suture from extending further in the direction of theproximal end 38 p of the second implantable anchor 38. A benefit of thefixed stopper knot 30 is that the position of the fixed tail can bemaintained relative to the second implantable anchor 38, whichsignificantly simplifies flexible member management while the secondimplantable anchor is passed through the cannula 48 and to the insertionsite at the second bone hole 52.

After attaching the flexible member 14 to the second implantable anchor38, the second implantable anchor 38 is then inserted into the secondbone hole 52, distal end 38 d first, as shown in FIG. 2f . As the fixedstopper knot 30 is constrained from passing proximally to flexiblemember engagement feature 20 of the second implantable anchor 38, itwill be maintained in that position relative to the anchor. Thus,flexible member retention is not only provided by compression betweenthe bone and the anchor, but also by the anchoring provided by the fixedstopper knot 30. Once the second implantable anchor 38 is positionedwithin bone hole 52, the terminal ends of first and second tails 22, 24are positioned such that the extend through and out of cannula 48 sothey are accessible to and able to be manipulated by a surgeon.

As shown in FIG. 2g , after the second implantable anchor has beeninserted into the second bone hole 52, tension can be applied to thefirst tail 22 by a surgeon pulling on the terminal end of the first tail22 in the direction of arrow F1. The action of the flexible member 14sliding through the finger trap 32 collapses the adjustable loop 44 andcompresses the tendon 46 against bone as a result of tensioning theportion of the construct connecting the first and second implantableanchors 12, 38. As the overhand knot 28 is designed to reduce stress onthe flexible member 14 and the finger trap 32, the finger trap 32 isprotected from damage in the event the direction of pull on the firsttail 22 is at an oblique angle to the finger trap 32, or in a directionother than direction D1 as shown in FIG. 1. One particular advantage ofthe construct described herein is that the construct can be tensionedafter the first and second anchors are implanted in bone, thussimplifying the procedure and enabling the desired amount of tension tobe set (and maintained) after implantation. This advantage makes theconstruct described herein particularly suitable for use with knotlessdouble-row repair constructs, and it enables the same type of anchor tobe used for both the medial and lateral rows.

Following tensioning, the cannula is removed, excess suture material istrimmed and removed, and the surgical wound is closed.

In some implementations, a threader, such as the threader 54 shown inFIG. 3, can be utilized by a surgeon to facilitate the insertion of thesecond tail 24 through the distal end 38 d of the second implantableanchor 38 when the tissue fixation and repair construct 10 is beingassembled at the surgical site. The threader 54 can include a couplingfeature 56 at its distal end for engaging the first tail 22, and ahandle 58 for grasping by a surgeon. In use, when the second implantableanchor 38 has been inserted through the cannula 48 via the use of aslotted inserter 60, the surgeon can pull on the handle 58 in thedirection of arrow F2 and thereby pull the threader 54, through a slot62 formed in the inserter 60, and thereby bring the fixed stopper knot30 into contact with the flexible member engagement feature 40 of thesecond implantable anchor 38.

Although the method is described using a technique in which the firstimplantable anchor is loaded with a single flexible member that willconnect to a single second implantable anchor, a person skilled in theart will appreciate that the first implantable anchor may be single,double, or triple loaded with collapsible sutures, each of which can beconnected to a second implantable anchor. FIG. 4 illustrates anexemplary embodiment of a tissue fixation and repair construct 10′ thatincludes a first implantable anchor 12′ that is loaded with a firstflexible member 14′ and a second flexible member 14″. As shown in thisembodiment, the first and second flexible members 14′, 14″ arestructurally the same as the flexible member 14 described above andillustrated in FIGS. 1-2 g, and the first implantable anchor 12′ isstructurally the same as the first implantable anchor 12 (also describedabove and illustrated in FIGS. 1-2 g). The flexible member 14 and thesecond flexible member 14′ are each coupled to a flexible memberengagement feature 20′ of the first implantable anchor 12,′ and arethereby retained in engagement with the first implantable anchor 12′.

In another embodiment illustrated in FIGS. 5-6 d, also useful in adouble-row fixation repair, a tissue fixation and repair construct 110includes a first implantable anchor 112 and a pre-spliced suture loop114 attached thereto. The first implantable anchor 112 can be the sameas or similar to first implantable anchor 12 described above and, assuch, can include a lumen 118 that can be the same as or similar to thelumen 18, and an engagement feature 120 that can be the same as orsimilar to the first flexible member engagement feature 20. Thepre-spliced suture loop 114 can be attached at its distal end 114 d tothe first implantable anchor 112. By way of example the distal end 112 dcan have a fixed stopper knot 130, similar to fixed stopper knot 30, formaintaining engagement between the pre-spliced suture loop 114, andparticularly its distal end 114 d, and the first implantable anchor 112,and thus prevent movement of the distal end 114 d through the lumen 118.The pre-spliced suture loop 114 can include a spliced region 132 throughwhich the pre-spliced suture loop 114 is threaded through itself tothereby form a loop 144. The loop 144 can be adjusted (i.e., closed) bypulling on a proximal end 114 p of the pre-spliced suture loop 114 inthe direction of arrow F3. The flexible member 114 can also include anoverhand knot 128 formed thereon, which is located distally adjacent tothe spliced region 132 relative to the first implantable anchor 112,such that the overhand knot 28 substantially abuts the spliced region132. The overhand knot 128 is configured to help maintain the integrityof the spliced region 132, and to enable a portion of the flexiblemember 114 to pass through the overhand knot 128 in such a way that theportion can be slidably moved through the overhand knot 128 in responseto tension applied by a surgeon in the direction of arrow F3. A personskilled in the art will appreciate that although a small gap may existbetween the overhand knot 128 and the spliced region 132 such that theoverhand knot 128 does not abut the spliced region 132 so as to be indirect contact with the spliced region 132, the overhand knot 128 cannevertheless be considered to substantially abut the spliced region 132due to any number of facts, such as manufacturing tolerance. Althoughthe overhand knot 128 is shown and described as an overhand knot, whichmay be beneficial in surgical procedures due to its low profile, anytype of knot known to one of ordinary skill in the art that is capableof achieving the functionality described herein may also be used in lieuof an overhand knot, such as a hitch knot. The overhand knot 128 isformed by the flexible member 114 itself. However, in other embodiments,another flexible member can be attached to the flexible member 114 toform the overhand knot 128 (e.g., tied around the flexible member 114 toform the overhand knot 128 thereon).

An exemplary method of fixing soft tissue, such as a tendon 146, usingthe tissue fixation and repair construct 110 is described with referenceto FIGS. 6a-6d . Similar to the method described above and illustratedin FIGS. 2a-2g , the method illustrated in FIGS. 6a-6d can be performedin a minimally invasive manner, e.g., arthroscopically, through acannula (not shown) that can be disposed through a patient's skin. Aperson skilled in the art will recognize other ways by which theprocedures described herein can be performed, including through three ormore cannulas, a single cannula, or through no cannula at all. Further,other types of procedures, such as open procedures, can be used inconjunction with the present disclosures, which may not require acannula.

FIG. 6a shows the tissue fixation and repair construct 110, wherein thefirst implantable anchor 112 has been inserted into a first bone hole136 formed in a portion of a bone 150. While the first implantableanchor 112 and a portion of the pre-spliced suture loop 114 are disposedwithin the bone hole 136 and the subject's body, the remainder of thepre-spliced suture loop 114 extends through a cannula (not shown) andout of the subject's body. A portion of the pre-spliced suture loop 114is passed through or around the tendon 146 after the first implantableanchor 112 has been inserted into the first bone hole 136, as shown inFIG. 6b . Subsequently, a second bone hole 152 is then formed in aportion of bone 150 adjacent to the first bone hole 136, as shown inFIG. 6c . The loop 144 of the pre-spliced suture loop 114 is thencoupled to a coupling suture 138 a of an implantable anchor assembly138. The coupling suture 138 a is coupled to a second implantable anchor138 b at an eyelet 138 c located at a proximal end 138 p of the secondimplantable anchor 138 b, and at a first prong 138 e at a distal end 138d. After being coupled to the loop 144, the second implantable anchor138 b is then inserted into the second bone hole 152, as shown in FIG.6d . The pre-spliced suture loop 114 is then tensioned by pulling on theproximal end 114 p of the pre-spliced suture loop 114, which collapsesthe loop 144 and tensions the coupling suture 138 a. As the couplingsuture 138 a is tensioned, the second implantable anchor 138 b isrotated in the second bone hole 152, such that the first prong 138 eengages the walls of the second bone hole 152 to lock the secondimplantable anchor 138 b in the second bone hole 152, thereby anchoringthe tendon 146 in place. An exemplary embodiment of such a secondimplantable anchor, which can be used in conjunction with the constructsand relating teachings provided for herein, includes a Bioknotless RCSuture Anchor, which is commercially available from DePuy Mitek, Inc.

With each of these configurations, the tissue fixation and repairconstructs 10, 110 can be tensioned after both the first implantableanchors 12, 112 and the second implantable anchors 38, 138 b have beenfully inserted into their respective bone holes.

Although the constructs and fixation methods described above are shownwith respect to a tissue fixation and repair construct having twoimplantable anchors and at least one flexible member, otherconfigurations featuring additional implantable fixed using methodssimilar to those described above with respect to the embodiments ofFIGS. 1-2 g and 5-6 d. For example, FIG. 7 illustrates a double rowrepair in which four implantable anchors (two medial row and two lateralrow) and four flexible members are used to secure a tendon 700. As shownin FIG. 7, first and second medial implantable anchors 701, 702 andfirst and second lateral implantable anchors 703, 704, each of which canbe substantially the same as the first and second implantable anchors12, 38, are provided. It is understood, however, that a different anchortype, such as the anchor shown in FIGS. 5-6 d, can be used for thelateral row as compared to the medial row. First, second, third, andfourth flexible members 705-708 are also provided, each of which can besubstantially the same as the flexible member 14 (or 114) and each ofwhich having the same structural features as flexible member 14 (or 114)described above, are provided and can be inserted into bone holes formedin a portion of bone 711 in a similar manner to the first and secondimplantable anchors 12, 38. As shown, the first and second flexiblemembers 705, 706 are coupled to the first medial implantable anchor 701to form a first double construct 709, and the third and fourth flexible707, 708 are coupled to the second medial implantable anchor 702 to forma second double construct 710. The first and second medial implantableanchors 701, 702 can be installed into the bone 705 in a manner similarto the first implantable anchor 12 and flexible member 14 as describedabove. The flexible members 705-708 can then be passed through thetendon 700 in a manner similar to that described above with respect toflexible member 14. The first lateral implantable anchor 703 can beloaded onto the first and fourth flexible members 705, 708 and thesecond lateral implantable anchor 704 can be loaded onto the second andthird flexible members 706, 707. This loading results in a criss-crossflexible member pattern that provides enhanced support and fixation. Thefirst and second lateral implantable anchors 703, 704 can then beinstalled into the bone 705, each across from the first and secondmedial implantable anchors 701, 702 respectively, and the first throughfourth flexible members 705-708 can be tensioned in a manner similar tothe tensioning of the flexible anchor 14, thereby securing the tissue inplace.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A tissue repair construct, comprising: a firstimplantable anchor having an engagement member and at least one boneengaging feature on an outer sidewall thereof; and a flexible memberhaving an intermediate portion coupled to the engagement member andhaving first and second tails extending therefrom, each of the first andsecond tails having a terminal end, wherein a portion of the first tailextends through an interior collapsible passage formed in a hollowportion of the second tail and a first knot formed in the second tailadjacent to the hollow portion, and wherein the second tail includes afixed knot intermediate the first knot and the terminal end of thesecond tail.
 2. The tissue repair construct of claim 1, wherein theintermediate portion is slidably coupled to the engagement member. 3.The tissue repair construct of claim 1, further comprising a secondimplantable anchor configured to be coupled to the second tail.
 4. Thetissue repair construct of claim 3, wherein the second implantableanchor is disposed proximate the fixed knot.
 5. The tissue repairconstruct of claim 1, wherein the terminal end of the first tail isconfigured to be coupled to the second tail.
 6. The tissue repairconstruct of claim 1, wherein the terminal end of the first tail isconfigured to be separated from the second tail.
 7. The tissue repairconstruct of claim 1, wherein the distance between the fixed knot andthe first knot is disposed at a distance from the fixed knot, thedistance approximately equal to 3-5 mm more than a length of the firstimplantable anchor.
 8. The tissue repair construct of claim 1, whereinthe interior collapsible passage is configured to be disposed outside ofa bone when the first implantable anchor is disposed in the bone.